Port septum with integral valve

ABSTRACT

A septum for a port is provided, the septum having a top wall and a side wall. The side wall can include a pressure-activated valve element for regulating the flow of fluid across the valve. The curvature of the side wall and the geometry of the sidewall and the housing can be tailored to bias the valve element to open at different pressures during infusion and aspiration. The side wall can also include an extended portion that can function as a suture wing for securing the port within a port pocket.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of newly allowed U.S. applicationSer. No. 13/680,397, filed Nov. 19, 2012 and is hereby incorporated byreference.

FIELD OF THE INVENTION

The present invention relates to implantable ports, and morespecifically, to a septum for a valved implantable port.

BACKGROUND OF THE INVENTION

Certain medical treatments require implantation of one or moresubcutaneous ports, such as vascular access ports. A port is typicallycomposed of (i) a housing, which defines a reservoir; (ii) aself-sealing septum, which covers and fluidly seals the reservoir; and(iii) an outlet through which fluid can pass between the reservoir and acatheter attached to the port. The port outlet is typically connected tothe proximal end of a catheter, with the distal tip of the catheterterminating at a target location within the body, such as the junctionof the superior vena cava and the right atrium. Following implantation,the port reservoir can be fluidly accessed with a needle, such as anon-coring infusion set, providing the ability to infuse and aspiratefluid to and from the target location. The port housing is typicallymade from medical grade plastics or metals, and the septum is typicallymade of an elastomeric material such as silicone.

Port catheters that are indwelling for extended periods of time pose therisk that blood may reflux into the catheter where it can clot,occluding the catheter or port reservoir, and/or potentially leading toinfection. To prevent reflux, a port may incorporate an internal valve,such as the PASV® Valve provided by AngioDynamics, Inc. (Latham, N.Y.).Internal valves typically include a valve element made from anelastomeric disk that has one or more slits therein. When a fluidpressure differential across the valve reaches a sufficient threshold,the valve element deforms so that the edges of the slit or slits areseparated and fluid can flow across the valve. The press necessary todeform the valve element depends on variables which may include thethickness, shape, durometer, and elastic properties of the valvematerial being used.

Conventional valved ports typically include a valve housing configuredwithin the port body for keeping the valve element secure. For example,referring to prior art FIG. 1, the port 10 housing defines a reservoir40 that is fluidly sealed with a self-sealing septum 20. The port 10also includes an outlet 45 and a flexible valve element 30 with apressure activated slit 35 for regulating the flow of fluid between thereservoir and an attached catheter 15. The flexible valve element 30 canfor example be circular, and secured within the port 10 by a valvehousing 50 that circumferentially runs along the inner wall of theoutlet 45 and includes some type of protrusion for securing edges of thevalve element 30. The valve housing functions to secure the elastomericelement in place, so that it does not become compromised or dislodgedduring procedures requiring higher pressures and flow rates, such aspower injection and dialysis. Since conventional valved ports require avalve housing for securing the elastomeric valve element, the profileand footprint of the port is increased relative to ports without valves.It would be desirable to provide a port that preserves thereflux-preventive qualities of conventional valved ports, with adecreased profile and footprint to improve patient comfort, while alsominimizing the cost and complexity of manufacturing the valved port.

SUMMARY OF THE INVENTION

The invention addresses the needs above by providing, in one aspect, avalved port having an integrated septum and valve element. The valveelement provides control over the flow of fluid between the portreservoir and the catheter, helping to prevent reflux and infection.Additionally, because the valve element is integral to the septum, theneed for a separate valve housing is obviated, resulting in a decreasedport profile and footprint relative to valved ports known in the art,further providing a cost savings in the manufacturing process.

In another aspect, the invention is an elastomeric septum for a port,having a top wall and a side wall extending from the top wall. The sidewall includes a valve element having a slit adapted to permit fluid flowtherethrough when acted upon by a threshold pressure.

In another aspect, the invention is a port for fluid access to a targetlocation within a human body, the port including a housing defining areservoir, an opening and an outlet, and an elastomeric septum disposedwithin the opening to fluidly seal the opening. The septum includes atop wall and a side wall, the side wall including a valve element havinga slit adapted to permit fluid flow between the reservoir and a portionof the outlet when acted upon by a threshold pressure.

In another aspect, the invention is a port for fluid access to a targetlocation within a human body, the port including a rigid housingdefining a reservoir, an opening and an outlet, and an elastomericseptum disposed within the opening to fluidly seal the opening. Theseptum includes a top wall and a side wall, the side wall including anextended elastomeric portion adapted to extend beyond a surface of therigid port housing.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing purposes and features, as well as other purpose andfeatures, will become apparent with reference to the description andaccompanying figures below, which are included to provide anunderstanding of the invention and constitute a part of thespecification, in which like numerals represent like elements, and inwhich:

FIG. 1 is a perspective cutaway view of a prior art valved port;

FIGS. 2A and 2B are cross-sectional and perspective views of a septumand a port assembly according to exemplary embodiments of the invention;

FIGS. 3A-3F front and cross-sectional views of septa according toexemplary embodiments of the invention;

FIGS. 4A and 4B are exploded and perspective views of a port assemblyaccording to exemplary embodiments of the invention;

FIGS. 5A-5C are front and cross-sectional views of a port assemblyaccording to exemplary embodiments of the invention; and

FIGS. 6A and 6B are perspective views of a port assembly according toexemplary embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention can be understood more readily by reference to thefollowing detailed description, the examples included therein, and tothe Figures and their following description. The drawings, which are notnecessarily to scale, depict selected preferred embodiments and are notintended to limit the scope of the invention. The detailed descriptionillustrates by way of example, not by way of limitation, the principlesof the invention. The skilled artisan will readily appreciate that thedevices and methods described herein are merely examples and thatvariations can be made without departing from the spirit and scope ofthe invention. It is also to be understood that the terminology usedherein is for the purpose of describing particular embodiments only andis not intended to be limiting.

Referring to FIG. 2A, a septum 100 includes a top wall 120 having athickness t₁, and a side wall 110 having a length l and thickness t₂,the side wall 110 extending from the top wall 120 and defining a cavitybeneath the top wall 120. The side wall 110 preferably includes apressure actuated valve element 130 integrated therein, the valveelement 130 having one or more slits 135 therethrough. While the septum100 can be of any suitable size or shape, in preferred embodiments, thethickness t₁ of top wall 120 of the septum 100 is preferably between 0.2and 0.25 inches, while the thickness t₂ of the side wall 110 ispreferably between 0.0085 and 0.0110 inches. The length l of the sidewall 110 is preferably from 0.15 to 0.20 inches. The septum 100 can alsobe made of any suitable material, but is preferably made of silicone,more preferably of 55 durometer shore A silicone.

Referring to FIGS. 2A and 2B, the septum 100 is depicted in the drawingsas having a substantially planar and circular top wall 120, with asidewall 110 extending circumferentially and roughly linearly along theperiphery of the top wall 120 and having constant depth and thickness.However, the septum may be made in any suitable shape. The top wall 120may be any suitable shape, including oval, square, triangular, polygonalor irregularly shaped. The surface of the top wall 120 may be planar,domed, convex, concave, of constant or variable thickness, or any othersuitable size or shape. The side wall 110, in preferred embodiments,extends roughly perpendicularly to a plane defined by the top wall 120.However, the side wall 110 may, in certain embodiments, extend at anangle other than 90° from the top wall. Though depicted in the drawingsas extending roughly linearly, the side wall 110 may, in certainembodiments, be curved as it extends away from the top wall 120, and thearea enclosed by the side wall 110 may be constant or variable dependingon the distance from the top wall 120. Similarly, the side wall 110 mayhave constant or variable thickness. Additionally, in certainembodiments the side wall 110 may not extend along the entirecircumference of the top wall 120, but instead may extend only along aportion of the circumference of the top wall 120.

The slit or slits 135 of the valve element 130 are designed so thattheir respective edges remain closed and adjacent to one another and donot permit fluid to flow through the valve element 130 at low pressuresin the range of normal blood pressure. However, when acted upon by afluid pressure in excess of a predetermined threshold, which may beabove normal or even elevated blood pressures to prevent leakage, theedges of the slits are displaced, separating to form an aperture throughwhich fluid can flow. The slit or slits 135 of the valve element 130 maybe any suitable shape and dimension, for example as disclosed in U S.Publication No. 2005/0171488 by Weaver et al, entitled “PressureActivated Safety Valve with High Flow Slit”, the entire disclosure ofwhich is incorporated herein by reference.

In certain embodiments, such as those of FIGS. 3A, 3C and 3E, the valveelement 130 has a different curvature and thickness relative to theremainder of the side wall 110. The thickness of the wall at the valveelement 130 may be thicker, thinner, or variable relative to otherportions of the side wall 110. The variability of thickness in the sidewall 110 or valve element 130 can serve multiple functions, such as forexample, conforming to size constraints or gaps between port housingelements, thresholding the valve element 130, or providing an alignmentelement for the slit 135. The valve element 130 is depicted throughoutthe drawings as roughly circular, but it may be of any suitable shape,including oval, rectangular, polygonal, or irregular. For example, thevalve element 130 may be shaped to include both curved and straightedges. Additionally, although the valve element 130 is depictedthroughout the drawings as having a single slit 135 oriented roughlyvertically, any suitable number, shape and orientation of slits 135 maybe used, including without limitation intersecting slits, parallelslits, curved slits, S-shaped slits, angled slits, and vertical,horizontal, diagonal, or slits of other orientations.

In other embodiments, such as the septum 200 shown in FIGS. 3B, 3D and3F, the side wall 210 and the valve element 230 have similar oridentical curvatures and thickness. The curvature of the valve element230 shown in FIGS. 3B, 3D and 3F can create a directional bias. Forexample, the curvature shown in FIGS. 3B, 3D and 3F biases the valveelement 230 so that the pressure threshold is lower for flow out of theport (infusion) than the threshold for flow into the port (aspiration).

As is shown in FIGS. 4A and 4B, a port 300 of the invention preferablyincludes a septum 100 as described above, upper and lower housingportions 310, 320, and an outlet 330 that can attach to a catheter.Because ports, of the invention position the valve element 130 withinone or both of the housing portions 310, 320, they may require a smallerprofile and footprint than conventional valved ports. In certainembodiments, the septum 100 is positioned between upper and lowerhousing portions 310, 320. The lower housing portion 320 preferablyincludes an optional inner wall 325 that defines a reservoir 324 forfluid transfer. The slit 135 and valve element 130 align with upperhousing aperture 316 and lower housing aperture 326 to allow fluidcommunication across the valve element 130. The port housing and theoutlet can be made of any suitable medical grade material known in theart. In preferred embodiments, the housing and the outlet are made oftitanium, stainless steel, polysulfone, acetal, or PEEK.

As shown in FIGS. 5A-C, the inner wall 425 of the lower housing 420 caninclude an alignment feature 436 that engages the valve element 130 ofthe septum 100. The alignment feature 436 includes an aperture that isopen to the reservoir 424 formed by the inner wall 425. The alignmentfeature 436 is shaped to align with the edges of the valve element 130and apply pressure to the inner surface of the valve element 130 so thatit withstands variations in pressure and fluid flow through the slit orslits 135 without being displaced. In certain embodiments, the alignmentfeature 436 can apply pressure perpendicular to the surface of the valveelement 130. In other embodiments, the alignment feature may applypressure at angles, which can optionally correspond with angled surfacesof the valve element. In addition, angled pressure configurations can beconfigured to manipulate the surface of the valve element 130 and/or theside wall 110, thereby changing the curvature of the valve element 130relative to the side wall 110. Optionally, the alignment feature can beshaped to apply lateral force or tension to the valve element 130 as isdisclosed in U.S. Publication No. 2012/0256114 by Buiser et al. entitled“Power Injectable Valve Designs,” the entire disclosure of which isincorporated herein by reference. Compared to conventional valved ports,the instant invention provides enhanced securement and reliability forthe valve element since it is part of a larger integral component,increasing the performance and safety of the valve, especially duringhigh pressure applications.

Pressure is also applied to the outer surface of valve element 130, incertain embodiments, by a surface of the outlet 430. The outlet 430 canalso be shaped to align with the edges of the valve element 130 andapply pressure in the various manners described above for the alignmentfeature 436 to gain the same advantages. In certain embodiments, theoutlet 430 fits securely against an aperture 416 of the upper housing410. In certain embodiments, the outlet 430 is secured against theaperture 416 by a press fit, laser weld, sonic weld, adhesive threadedfit, or any other suitable securement method known in the art.

The alignment feature 426 and the outlet 430 can apply pressure to thevalve element 130 and the side wall 110 irrespective of differences incurvature or thickness, or other differences, between the side wall 110and the valve element 130. Although they are depicted in FIG. 5 as beingaligned with one-another, the alignment feature 426 and the outlet 430may be offset, for example by having different diameters, so that theyinterlock and apply tension to the valve element 130. Additionally,off-setting the diameters of the alignment feature 426 and the outlet430 can bias the valve element 130 to preferentially open in onedirection. Biasing the valve can alter the pressure required to open thevalve for aspiration relative to that required to open the valve forinfusion. In an exemplary embodiment, the ratio of aspiration pressureto infusion pressure is approximately 4:1.

As shown in FIG. 6A, the septum 500 optionally includes an integralsuture wing 500W for securing the port to the tissue of a patient usingsutures. Similar to the securement of a valve element, securement of asuture wing element would otherwise require a securement housing. Thesuture wing 500W can be formed from extended portions of the septum sidewall and configured to fit and extend between gaps formed between theupper and lower housings of the assembled port. The suture wings extendbeyond the surface of the port housing for suturing the port within asubcutaneous port pocket. Since the septum material is flexible andrelatively easy to cut, the suture wings 100W can be manufactured withextra material and subsequently cut to customize a fit within thepatient's anatomy and to match a desired suture pattern within thesubcutaneous port pocket. Alternatively, as shown in FIG. 6B, the septum600 may include one or more feet 600F with extended portions of theseptum side wall extended over openings in the feet to minimize ingrowthwithin the suture openings.

In certain embodiments, the septum includes features that permit it tofit snugly and securely within the port. Such features may include tabs,ridges, recesses, or any other suitable securement features known in theart. The septum may be secured to the port, in certain embodiments, by afastener such as a stud or a rivet, or with an adhesive or any othersuitable means known in the art. In other embodiments, the inner wall ofa lower housing has outer diameter sized to be slightly greater than theinner diameter of the side wall of the septum, so that the side wall isslightly stretched and held in place when positioned over the lowerhousing.

The desired septum geometry can be formed by a number of variousmanufacturing and machining techniques known in the art. For example,high precision machining using drills or lasers can cut down the septumfrom a larger sheet or block of silicone. Alternatively, a siliconeinjection molding apparatus can be used to form a desired septumgeometry. In certain embodiments, the valve element may be formedintegrally to the septum, but may also include stiffening elements orother materials chosen to advantageously affect opening and closingcharacteristics, for example as described in U.S. Pat. No. 7,435,236 toWeaver, et al. entitled “Pressure Actuated Valve with Improved BiasingMember,” the entire disclosure of which is incorporated herein byreference. In alternate embodiments, the septum may be formed asmultiple pieces, and the valve element and/or the side wall may becomposed of a material different than the top wall. In certainembodiments, the multiple pieces may be joined together with anadhesive, by overmolding, or by the use of other suitable means.

Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill in the artwithout departing from the spirit and scope of the invention as claimed.Accordingly, the invention is to be defined not by the precedingillustrative description but instead by the spirit and scope of thefollowing claims.

The invention claimed is:
 1. A port device, comprising: a housingcomprising a housing outlet aperture; a septum comprising a valve;wherein the valve comprises at least one slit; an outlet stem; analignment feature configured to engage the valve; and wherein thehousing outlet aperture is configured to be aligned with the valve andthe outlet stem.
 2. The device of claim 1, wherein the outlet stem isconfigured to be connected to a catheter.
 3. The device of claim 1,wherein the septum further comprises a side wall having a firstthickness and the valve has a second thickness.
 4. The device of claim3, wherein the second thickness is less than the first thickness.
 5. Thedevice of claim 3, wherein the first thickness is less than the secondthickness.
 6. The device of claim 1, wherein the septum furthercomprises a needle-penetrable region.
 7. The device of claim 6, whereinthe needle-penetrable region is located on a top wall of the septum. 8.The device of claim 1, wherein the valve is configured to permit fluidflow therethrough when acted upon by an infusion pressure threshold andan aspiration pressure threshold, wherein the infusion pressurethreshold is lower than the aspiration pressure threshold.
 9. The deviceof claim 1, wherein the valve and the septum are of unitaryconstruction.
 10. A port device comprising: a housing; a septum disposedwithin the housing and comprising a septum side wall having a firstradius of curvature and a valve having a second radius of curvature;wherein the curvature of the first radius and the second radius areconfigured to create a directional bias in the valve.
 11. The device ofclaim 10, further comprising an outlet stem.
 12. The device of claim 10,wherein the housing further comprises a housing outlet aperture.
 13. Thedevice of claim 12, wherein the housing outlet aperture is configured tobe aligned with the valve and the outlet stem.
 14. The device of claim10, wherein the directional bias in the valve is configured such that aninfusion pressure threshold is lower than an aspiration pressurethreshold.
 15. The device of claim 10, wherein the valve and the septumare of unitary construction.